LTBI Campaign Message Testing project-summary and determination

Print Date: 2/20/20

Title:

Formative Work to Understand Influences, Barriers, and Facilitators for LTBI Testing and Treatment among High Risk Non-U.S.
Born Individuals and the Healthcare Providers that Serve Them

Project Id:

0900f3eb81a93d31

Accession #:

NCHHSTP-CT-12/23/19-93d31

Project Contact:

Parmer_John E. (bkz8)

Organization:

NCHHSTP/DTBE/CEBSB/CT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

09/30/2019

Estimated Completion Date:

09/29/2020

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO
Review

Not Research

1/24/20

Dodson_Janella R. (jhd7) CIO HSC

1/24/20

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

PRA:
PRA Applies

ICRO:
Returned with No Decision

1/28/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

01/29/2020

Determination Start Date:

01/16/20

Description:

The United States reported 9,025 Tuberculosis (TB) cases during 2018. Although TB cases continue to decline, the annual
percentage decrease in case count and incidence rate from 2017 to 2018 is the smallest year-to-year decrease observed since
1993. Over two-thirds of total cases of TB disease in the U.S. occurred among non-U.S.-born persons. The most common countries
of birth among non-U.S.-born TB patients include Mexico, the Philippines, India, Vietnam, and China. More than 80% of U.S. TB
cases are now believed to be associated with longstanding untreated latent TB infection (LTBI). Expanding targeted testing and
treatment of LTBI is key to eliminating TB disease in the U.S. CDC has funded Weber Shandwick to develop and implement a
communication campaign under the CDC#s Office of the Associate Director (OADC) Blanket Purchase Agreement (BPA). In order
to develop an effective communications campaign that educates individuals at high risk for TB and the healthcare providers who
serve them, CDC DTBE seeks to conduct public health program activities for testing draft messages with consumers (in-language
mainly, but in English for Indian and Filipino audiences) and healthcare providers, and learn their preferences for seeking
information, and gain a better understanding of the various knowledge, attitudes, beliefs, and misconceptions around LTBI across
the different audience segments and geographic locations.

Goals/Purpose

CDC#s DTBE seeks to conduct public health program activities for testing messages with individuals who were born in the top six
countries of origin that contribute to the U.S.#s current TB rates#a critical target audience group that is considered at high risk for
TB disease - and the healthcare professionals (primary care physicians and nurses/nurse practitioners) that serve them. The
primary goal for this research effort is to explore and understand influences, barriers, and facilitators for testing and treating latent
tuberculosis infection (LTBI) in order to develop a communication campaign to reach these audiences.

Objective:

Project objectives for the public health program activities are as follows: # Understand levels of awareness, knowledge, attitudes,
beliefs, practices, and cultural influences related to TB and latent TB infection among at-risk consumer audiences and their
healthcare providers # Understand key barriers to latent TB infection testing and treatment # Understand key motivators to latent TB
infection testing and treatment, as well as trusted sources and messengers of health information # Assess the most effective
communications channels for information about latent TB infection for foreign-born community members and their healthcare
providers # Test key messages, materials, and creative to communicate about latent TB infection among key target audiences

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Asian, Healthcare Personnel, Hispanic or Latino

Tags/Keywords:

Latent Tuberculosis, Tuberculosis, Focus Groups, Interview

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Focus Group, Individual Interviews (Qualitative)

Methods:

DTBE has funded Weber Shandwick to conduct 12 in-person consumer focus groups with non-U.S.-born individuals considered at
high risk for TB. The majority of focus groups will be conducted in-language, with four conducted in English. We will also conduct 4
focus groups among nurses, nurse practitioners, and physician assistants, and 12 in-person interviews with primary care
physicians.

Collection of Info, Data or Biospecimen:

CDC is sponsoring, but not conducting data collection. Weber Shandwick will conduct all focus groups and interviews in three cities
representing different geographic regions in the U.S. Consumers participating in the focus groups will have immigrated from:
Mexico, the Philippines, India, Vietnam, China, and Guatemala. In each metropolitan area, sessions will be conducted with between
three and five consumer focus groups, between one and two focus groups with nurses, and four physician interviews. Cities were
selected based on 2018 TB case rate data, the latest population data, locations which would provide a geographically diverse
sample, as well as markets that have ethnic or in-language media outlets for each of our target consumer populations. The
metropolitan areas are: Los Angeles, California; Houston, Texas; and New York City, New York. Each metropolitan area#s TB case
rate exceeds the national average of 2.8 cases per 100,000 population and represents metropolitan areas with some of the highest
rates of TB within the U.S. Additionally, individuals born in the top countries of origin for TB are well-represented among the
populations of these cities. Focus groups sessions will last approximately 120 minutes. The in-person interviews will last
approximately 60 minutes. DTBE plans to seek OMB approval via the Health Message Testing System (HMTS) ICR # 0920-0572. A
level-setting activity will be conducted in each focus group prior to aided discussion around TB and LTBI. The activity will consist of
sharing brief information with the respondents, including definitions of terms and basic TB information (for consumer audiences),
and CDC guidelines (for healthcare providers). The team will also test a total of 4 message pillars, with two to four messages per
theme, across the 12 consumer focus groups, four nurses focus groups and 12 in-person interviews with physicians. Themes and
messages will be rotated across focus groups and interviews (to test all messages while not overburdening any one focus group or
interview).

Expected Use of Findings/Results:

The findings from these activities will inform a communication campaign strategy, messaging, creative, and tactics for a national
education campaign on latent TB infection to reach at-risk audiences and their healthcare providers.

Could Individuals potentially be identified based on
Information Collected?

Yes

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Contract

Latent Tuberculosis Infection Educational Campaigns and Communication Support

75D301-19F-05695

2020

3

Regulation and Policy
Do you anticipate this project will be submitted to

the IRB office
Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

Suggested level of risk to subjects Do you anticipate this project will be exempt research or non-exempt research
Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested documents of informed consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

John
Parmer

12/21/2021

CITI Biomedical Exp.
Date

CITI Social & Behavioral
Exp. Date

12/17/2022

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

Program
Lead

bkz8@cdc.
gov

404-6394598

Communications
Team

Data
DMP
Proposed Data Collection Start Date:

3/2/20

Proposed Data Collection End Date:

6/26/20

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - focus group and individual interview data

Public Access Justification:

The raw data collected by Weber Shandwick will be reflected in transcripts of up to 44 hours of focus group session and individual
interview activity. CDC does not have plans to make available these raw data, however these data will be used to develop public
messages in campaign materials that will be made publicly available.

How Access Will Be Provided for Data:

Not applicable given the description above.

Plans for Archival and Long Term Preservation:

Raw data from this data collection effort will never become part of a system of records containing permanent identifiers that can be
used for retrieval. CDC has no direct contact with participants and no identifiers will be available.

Spatiality
Country

State/Province

County/Region

United States

Texas

Houston

United States

New York

New York

United States

California

Los Angeles

Dataset
Dataset Title

Dataset yet to be
added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External Access
URL

Download
URL

Type of Data
Released

Collection Start
Date

Collection End
Date